A -- Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Other Aging Related Diseases

The National Institute on Aging (NIA), National Institutes of Health (NIH) is seeking small businesses with the capabilities to evaluate acute and chronic toxicity in rodents, dogs, and rabbits of drugs which are proposed to have potential use in the treatment of Alzheimer's disease and other aging-related diseases. The data generated from those studies will be used as part of the filing of an Investigational New Drug Application to the Food and Drug Administration in order to receive approval to use the drugs in humans. The work to be performed includes toxicity evaluations using fully audited Good Laboratory Practices (GLP) in studies such as: single-dose and 7-day dose range finding oral toxicity study in rats; single-dose and 7-day dose range finding oral toxicity study in dogs; expanded acute intravenous toxicity study in rats; expanded acute intravenous toxicity study in dogs; functional observation battery evaluations of neurobehavioral effects in rats; 30 day oral toxicity study in rats; 30 day oral toxicity study in dogs; 90 day oral toxicity study in rats; 90 day oral toxicity study in dogs; acute vascular irritation study in rabbits; cardiopulmonary evaluation by intravenous administration in dogs; and other ancillary studies (e.g. in vitro mutation assays). The following qualification criteria must be met at the time a proposal is submitted: (1) The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in the December 22, 1978 Federal Register (Volume 43, No. 247, pp. 59986-60025). GLP Regulations are available on the World Wide Web (WWW) at www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm and GLP Regulations Questions and Answers are available at www.fda.gov/cder/guidance/old004fn.pdf. A copy of the most recent FDA GLP inspection report must be included in the proposal; and, (2) The Contractor's animal facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing the latest accreditation report. Information about AAALAC accreditation is available on the WWW at www.aaalac.org. The Contractor must also provide an animal welfare assurance indicating compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, information for which is available on the WWW at http://ohrp.osophs.dhhs.gov/index.htm and http://grants.nih.gov/grants/olaw/olaw.htm. The full Statement of Work, an Attachment to the Statement of Work, and Technical Evaluation Criteria for this project are attached to this notice. THIS IS NOT A REQUEST FOR PROPOSALS (RFP) and does not commit the Government to award a contract now or in the future. No RFP is available at this time. Small business concerns that believe they possess the capability necessary to perform the work described above and in the attached documents should submit an original and two (2) copies of their capability statement to the Contracting Officer at the address shown by December 3, 2003. Electronic copies of capability statements will also be accepted and can be emailed to contact@example.gov The North American Industrial Classification System (NAICS) code is 541710. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested parties may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 calendar days of this notice. No collect calls will be accepted.